Adding vericiguat to guideline heart-failure therapy for people with decompensated heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled Phase 1 trial enrolling 70 patients with decompensated heart failure and reduced ejection fraction who present to the emergency department at a single center in Rawalpindi, Pakistan. Eligible patients have LVEF ≤45% with elevated NT-proBNP and will be randomly assigned by lottery to receive vericiguat or placebo in addition to guideline-directed medical therapy (which may include sacubitril/valsartan). Baseline clinical data, NYHA class, and biomarkers will be recorded and patients will be followed for hospitalizations for heart failure, cardiovascular death, and adverse events. The study tests safety and early clinical outcomes of adding vericiguat in an acute decompensated setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients diagnosed with decompensated heart failure (patients with left ventricular ejection fraction ≤45% presenting with NYHA functional class III-IV symptoms or worsening class II symptoms. Along with elevated natriuretic peptide levels defined as NT-proBNP \>1000 pg/mL in patients with sinus rhythm and \>1600 pg/mL in patients with atrial fibrillation in the absence of alternative causes of biomarker elevation)

Exclusion Criteria:

* Patients with blood pressure \<100 mmHg;
* concurrent or anticipated use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type 5 inhibitors
* use of intravenous inotropes or implantable left ventricular assist devices (on medical record)

Where it's running

• Armed Forces Institute of Cardiology. Pakistan
  Rawalpindi, Punjab Province, Pakistan Recruiting

Study contacts

• Study coordinator: Dr Khawaja Danish Ali, MBBS
• Email: khawajadanishali@gmail.com
• Phone: +923448890893

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.